Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417014
Status:
UNKNOWN
Last Update Posted:
2013-08-02
First Post:
2006-12-27
Brief Title:
Combination Chemotherapy andor Radiation Therapy in Treating Young Patients With Hodgkins Lymphoma
Sponsor:
Childrens Cancer and Leukaemia Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Hodgkins Disease Study
Status:
UNKNOWN
Status Verified Date:
2006-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy such as chlorambucil vinblastine procarbazine and prednisolone work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill cancer cells Giving more than one drug combination chemotherapy together with radiation therapy may kill more cancer cells
PURPOSE This clinical trial is studying how well giving combination chemotherapy andor radiation therapy works in treating young patients with Hodgkins lymphoma
PURPOSE This clinical trial is studying how well giving combination chemotherapy andor radiation therapy works in treating young patients with Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Establish a uniform practice for the management of children with Hodgkins lymphoma
Document the long-term side effects of such management
Establish whether or not children can be safely managed without staging laparotomy and splenectomy
Establish whether or not chlorambucil vinblastine procarbazine hydrochloride and prednisolone CLVPP is an effective alternative to mechlorethamine vincristine procarbazine hydrochloride and prednisone MOPP chemotherapy
OUTLINE This is a multicenter study Patients are assigned to 1 of 3 treatment regimens according to disease stage and presence of bulky mediastinal disease
Involved-field radiotherapy for patients with stage IA nodal disease Patients undergo involved-field radiotherapy 5 days a week for 4 weeks
CLVPP chemotherapy for patients with all other stages of disease AND no bulky mediastinal disease Patients receive CLVPP chemotherapy comprising oral chlorambucil oral procarbazine hydrochloride and oral prednisolone on days 1-14 and vinblastine IV on days 1 and 8 Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
CLVPP chemotherapy and radiotherapy for patients with all other stages of disease AND bulky mediastinal disease Patients receive CLVPP chemotherapy as above Patients then undergo radiotherapy to the mediastinum beginning 2 weeks after completing the last course of CLVPP chemotherapy
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 358 patients were accrued for this study
Establish a uniform practice for the management of children with Hodgkins lymphoma
Document the long-term side effects of such management
Establish whether or not children can be safely managed without staging laparotomy and splenectomy
Establish whether or not chlorambucil vinblastine procarbazine hydrochloride and prednisolone CLVPP is an effective alternative to mechlorethamine vincristine procarbazine hydrochloride and prednisone MOPP chemotherapy
OUTLINE This is a multicenter study Patients are assigned to 1 of 3 treatment regimens according to disease stage and presence of bulky mediastinal disease
Involved-field radiotherapy for patients with stage IA nodal disease Patients undergo involved-field radiotherapy 5 days a week for 4 weeks
CLVPP chemotherapy for patients with all other stages of disease AND no bulky mediastinal disease Patients receive CLVPP chemotherapy comprising oral chlorambucil oral procarbazine hydrochloride and oral prednisolone on days 1-14 and vinblastine IV on days 1 and 8 Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity
CLVPP chemotherapy and radiotherapy for patients with all other stages of disease AND bulky mediastinal disease Patients receive CLVPP chemotherapy as above Patients then undergo radiotherapy to the mediastinum beginning 2 weeks after completing the last course of CLVPP chemotherapy
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 358 patients were accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20585 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000454559 | REGISTRY | None | None |